Recall archive / FDA device enforcement
Blue Silicone, Reusable Silicone Seal 6 - 12 FR. Model Number: CS-B612. The reusable silicone seals fit over the biop... — FDA record Z-2139-2025
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Jun 18, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Blue Silicone, Reusable Silicone Seal 6 - 12 FR. Model Number: CS-B612. The reusable silicone seals fit over the biopsy port of endoscopes to seal off the working channel. Some contain a lumen which allows instruments to be passed through the seal and minimize or prevent fluid leakage during endoscopic procedures.
- Reason
- Discrepancies between sterilization instructions in the Japanese language product package inserts and those published in the manufacturer product Instructions For Use (IFU).
- Classification
- Class II
- Recalling firm
- Olympus Corporation of the Americas
- Quantity
- 19 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-2139-2025
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Model Number: CS-B612. UDI-DI: 00821925038318, 00821925001176. All lot numbers |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
International distribution to the country of Japan.
No US distribution state could be established from this record. Check the official notice.
Dates in the source
- Report date
- Jul 30, 2025
- Recall initiation date
- Jun 18, 2025
- Center classification date
- Jul 21, 2025
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.